I Ethics approval I Modules I Use of Alfred services I

I External applicants I Ethics Committee fees I

I Submitting your application to the Ethics Committee I

I Legal and regulatory requirements I I Registration of clinical trials I

Ethics approval
Most research involving humans will require ethical review, and the level of review will be commensurate with the level of risk to which participants are exposed.

Research that can be exempted from review
If the research has negligible risk and involves the use of totally non-identifiable data about humans, ethical review may not be necessary.

If you think your research is exempt from ethical review, please submit an ‘application-by-letter’ addressed to The Ethics Manager, Alfred Hospital, and email it to research@alfred.org.au. The letter should provide all details to justify a waiver of the requirement for ethical review.

Research that has negligible risk but does use data that could possibly identify individuals is not exempt from ethical review.

Low risk research
If the research cannot be exempt from review, is negligible or low risk, full ethical review may not be required. If you think your research fits into this category, please complete the low risk research or activities checklist (MS Word) and submit it to research@alfred.org.au for opinion.

More than low risk research
For all research more than low risk, full ethical review is required and you will be required to complete and submit a full application to the Ethics Committee for review and approval.

The application form consists of a number of modules with accompanying guidelines. Make sure you read the guidelines before completing the corresponding module.

Please also familiarise yourself with the Alfred Ethics Committee policies page, covering a range of research activities.

All applicants must complete and submit:

• Module 1 – Core Application Form
• Any other modules relevant to your project
• Module 6 – Alfred-specific financial details

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Use of Alfred services
Please note that where Alfred services are being used in the course of the study, a declaration will need to be signed by the relevant Resource Centre Manager. This applies to routine tests as well as additional tests.

Resource Centre Declaration forms and information are provided below. These are to be completed where applicable.

• Alfred Heart Centre Declaration form (18 KB, MS Word)
• Alfred Lung Function Laboratory Services Declaration form (42 KB, MS Word)
• Alfred Pathology Services Declaration form (26 KB, MS Word)
• Alfred & Baker IDI Gene Bank
• Nursing research
• Patient records
• Pharmacy
• Pharmacy - Request for Clinical Trials Pharmacy Costing (33 KB, MS Word)
• Radiation Safety Officer
• Radiation Services Guidelines (65 KB, MS Word)
• Radiation Services Declaration form (60 KB, MS Word)

External applicants
If you are an applicant who is not a staff member of The Alfred you must include at least one senior member of staff on the research team.

Ethics Committee fees (Ethics infrastructure fees)
Fees apply for certain categories of applications. For full details, see Fees.

Submitting your application to the Ethics Committee
Preliminary submission
To submit an application, download the appropriate modules and complete them (using Word). You will then need to submit a preliminary application by e-mail to research@alfred.org.au by the submission date. Any signatures and additional documentation that cannot be emailed are to be included in the full, hard copy submission. Please indicate on the relevant checklists any documents that you cannot submit by email and that you will provide in hard copy with your full submission.

The submission will be checked for completeness by the Ethics Manager and any omissions or changes requested will be conveyed to you by email. A Project Number will be allocated and you will be advised of this number plus the number of paper copies required and the date for full submission.

You will also be asked to submit an electronic version incorporating any requested changes, as some Ethics Committee members review projects online.

Full submission
You will receive detailed instructions from us. All documentation is to be collated, as instructed before full submission so that each item of supporting documentation is attached to each copy of the application form. Individual items such as indemnity statements, CVs, CTN forms and clinical trial agreements are to be placed with the original, paper application.

Legal and regulatory requirements
Commercially sponsored applications are usually accompanied by an indemnity statement, an insurance certificate and a Clinical Trial Agreement.

The Alfred Hospital insurers and lawyers have certain requirements regarding the wording of these documents and applicants and commercial sponsors should be familiar with these. The relevant documents are listed below.

VMIA guidelines for clinical trials
Guidelines for clinical trials for Victorian public hospitals 2007 (667 KB, PDF)

Clinical Trial Agreements

Clinical Trial Preparation Agreement ("Pre-Nup")

Instructions

Template (54 KB, MS Word)

Commercially Sponsored Trials

Instructions

Template (97 KB, PDF)

Investigator Initiated Trials

Instructions

Template (116 KB, MS Word)

Guidelines for compensation for injury resulting from participation in a company-sponsored clinical trial
Medicines Australia - Guidelines for Compensation (87 KB, PDF)

Form of indemnity for clinical trials
Form of Indemnity for Clinical Trials (76 KB, MS Word)

Clinical Trial Notification (CTN) Scheme Form
CTN Form (200 KB, PDF)

Registration of clinical trials
The International Committee of Medical Journal Editors (ICMJE) has adopted a policy that the member journals will only consider publication of clinical trials if the trial has been registered in a World Health Organisation (WHO)-accredited clinical trial registry. Trials can be registered with:

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This page was last modified on 21/11/08

URL: http://www.alfredresearch.org/ethics/applicat.htm

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